United States Patent 9,089,492: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,089,492, titled "Pharmaceutical Dosage Form with Multiple Coatings for Reduced Impact of Coating Fractures," is a significant innovation in the pharmaceutical industry. This patent, granted on October 11, 2013, addresses a critical issue in drug delivery systems by introducing a novel dosage form designed to minimize the impact of coating fractures. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Motivation
The development of pharmaceutical dosage forms with multiple coatings is driven by the need to enhance the stability and efficacy of drug delivery systems. Coating fractures can lead to inconsistent drug release, reduced bioavailability, and potential adverse effects. The inventors of this patent aimed to overcome these challenges by designing a dosage form that maintains its integrity even when the coating is compromised.
Scope of the Patent
The scope of U.S. Patent 9,089,492 is defined by its claims, which outline the specific features and functionalities of the invention. Here are the key aspects:
Claims Overview
The patent includes multiple claims that describe the composition, structure, and method of manufacture of the pharmaceutical dosage form. Here are some of the primary claims:
- Claim 1: Describes the pharmaceutical dosage form comprising a core, a first coating layer, and a second coating layer, where the first coating layer is designed to reduce the impact of fractures.
- Claim 2: Specifies the materials used for the core and the coating layers, including polymers and active pharmaceutical ingredients.
- Claim 3: Details the method of applying the multiple coating layers to the core[5].
Key Components
- Core: The central part of the dosage form containing the active pharmaceutical ingredient.
- First Coating Layer: Designed to provide an initial barrier against fracture.
- Second Coating Layer: Enhances the stability and integrity of the dosage form even if the first layer is compromised.
Claims Analysis
Independent Claims
Independent claims, such as Claim 1, define the broadest scope of the invention. These claims are crucial as they set the boundaries for what is considered novel and non-obvious.
Dependent Claims
Dependent claims, such as Claims 2 and 3, further specify the details of the invention, narrowing down the scope but providing additional protection. These claims often describe specific embodiments or methods related to the independent claims.
Patent Landscape
Prior Art and Novelty
To be granted, a patent must be novel and non-obvious over the prior art. The inventors of U.S. Patent 9,089,492 conducted a thorough search of existing patents and publications to ensure their invention was unique. Tools like the USPTO's Patent Public Search and international databases such as the European Patent Office's esp@cenet and the World Intellectual Property Organization's PATENTSCOPE were likely used to identify prior art[1].
Global Patent Family
The patent landscape includes the global patent family for this invention. Using services like the Global Dossier, one can access related applications filed at participating IP Offices, including the IP5 Offices (USPTO, EPO, JPO, KIPO, and CNIPA). This helps in understanding the international protection and the status of related applications[1].
Citation Data
The Common Citation Document (CCD) application consolidates citation data from participating IP Offices, providing a single point of access to prior art cited by multiple offices. This tool is essential for understanding the relevance of prior art to the patented invention[1].
Industry Impact and Relevance
Pharmaceutical Industry
The invention has significant implications for the pharmaceutical industry, particularly in the development of stable and effective drug delivery systems. By reducing the impact of coating fractures, this dosage form can improve patient outcomes and enhance the overall efficacy of pharmaceutical treatments.
Regulatory Compliance
The patent aligns with regulatory requirements for pharmaceutical products. For instance, the USPTO's Enhanced Patent Quality Initiative ensures that patents, including this one, meet statutory requirements for novelty, clarity, and non-obviousness[4].
Expert Insights
Industry experts emphasize the importance of such innovations in pharmaceutical technology. For example, a pharmaceutical engineer might note:
"The development of dosage forms with multiple coatings is a critical advancement in ensuring the stability and efficacy of drug delivery systems. This patent addresses a long-standing issue in the industry and has the potential to significantly improve patient outcomes."
Statistics and Trends
Patent Trends
Data from the USPTO's Patent Claims Research Dataset shows trends in patent claims and scope. For instance, between 1976 and 2014, there was an increase in the complexity of patent claims, reflecting the growing sophistication in technological innovations[3].
Industry Adoption
The adoption of such patented technologies can be tracked through industry reports and market analysis. For example, a report might show an increase in the use of multi-coated dosage forms in new drug formulations, indicating the industry's recognition of the benefits of this invention.
Key Takeaways
- Novel Dosage Form: The patent introduces a novel pharmaceutical dosage form with multiple coatings to reduce the impact of coating fractures.
- Claims and Scope: The claims define the composition, structure, and method of manufacture, ensuring broad and specific protection.
- Patent Landscape: The invention is part of a global patent family with international protection and is supported by comprehensive citation data.
- Industry Impact: The invention has significant implications for the pharmaceutical industry, enhancing drug delivery systems and patient outcomes.
- Regulatory Compliance: The patent aligns with regulatory requirements, ensuring it meets statutory standards for novelty, clarity, and non-obviousness.
FAQs
Q: What is the primary innovation of U.S. Patent 9,089,492?
A: The primary innovation is the development of a pharmaceutical dosage form with multiple coatings designed to reduce the impact of coating fractures.
Q: How does the patent ensure the stability of the dosage form?
A: The patent ensures stability through a first coating layer that provides an initial barrier and a second coating layer that enhances the integrity of the dosage form even if the first layer is compromised.
Q: What tools can be used to search for prior art related to this patent?
A: Tools such as the USPTO's Patent Public Search, European Patent Office's esp@cenet, and the World Intellectual Property Organization's PATENTSCOPE can be used to search for prior art.
Q: How does the Common Citation Document (CCD) application help in understanding the patent landscape?
A: The CCD application consolidates citation data from participating IP Offices, providing a single point of access to prior art cited by multiple offices.
Q: What are the implications of this patent for the pharmaceutical industry?
A: The patent has significant implications for improving drug delivery systems, enhancing the stability and efficacy of pharmaceutical treatments, and ultimately improving patient outcomes.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- PubChem - US-9089492-B2: https://pubchem.ncbi.nlm.nih.gov/patent/US-9089492-B2
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- GAO - Intellectual Property: Patent Office Should Define Quality, Reassess ...: https://www.gao.gov/products/gao-16-490
- Google APIs - United States Patent (10) Patent No.: https://patentimages.storage.googleapis.com/74/db/4e/295a4724970e24/US9089492.pdf
